This patent application is related to an apparatus and a set of parts used for diagnosing and testing/training pelvic floor musculature (tissue). It also includes a method for monitoring training of the pelvic floor in the absence of specialists.
During the last 50-60 years, it has been known that weakness in the pelvic floor tissue is one of the cause of urine leakage. During this time there has been an attempt to develop various measuring devices to help find the causes of the leakage, and to develop improved methods for evaluating the force in the pelvic floor in a reproducible and quantitative manner. These improvements would help specialists determine which persons should be treated in a conservative manner, and which persons should be treated operatively. Without knowledge of the normal and abnormal mechanical conditions in the pelvic floor, as well as the normal physiological and patohysiological conditions, this is problematic.
The most common method for evaluating the function of the pelvic floor is manual palpation. Such a method provides no reliable parameters, and the variation between different investigators is large.
Balloons have been used, and are still in use. Balloons are inserted into the vagina or the rectum. Since the balloon senses pressure changes without regard to directions, these results are also associated with large uncertainty. Additionally, one cannot know the changes of the balloon diameter during a test, nor the physical characteristics or the balloon. This has the consequence that it is not possible to calculate pelvic floor force from the pressure measurements.
Tubes working as electromyographic measurement electrodes have also been used. This method is also associated with a large uncertainty, since the electrical activity in the pelvic floor musculature is not proportional to the force output. In addition, great measurement uncertainty arises when the vaginal tissue moves relative to the inserted EMG sensor, i.e., a movement-induced increase in EMG activity arises, which increase is not related electrical activity in the tissue.
Conical devices that are inserted in the vagina have also been used. These conical devices have various weights. The weight is in the rage of 20 to 100 grams. Using these conical devices, one obtains a measure of the indirect force in the pelvic floor musculature. That is, if a conical device weighing e.g. 100 grams cannot be held in its place in the vagina, and falls out, the force output is less than 100 grams.
Important physiological and mechanical parameters of the pelvic floor musculature are not measured when the above methods are used. This is important since several conditions in the pelvic floor musculature may cause urine leakage. Therefore, it is important to obtain several measures of the pelvic floor function, both passive and active characteristics, like passive and active length/force-ratios.
Training of the pelvic floor musculature, usually prescribed by physicians, also has certain limitations; the persons may have trouble controlling whether they use the pelvic floor musculature, nor do they have any information regarding how large a force this musculature develops. Several different methods have been developed, all of them having the following weaknesses in general:
i) uncertainty whether the pelvic floor musculature is actually trained PA1 ii) uncertainty regarding the training load PA1 iii) uncertainty regarding intensity and duration of each training session.